Effectiveness and safety of dydrogesterone in regularization of menstrual cycle: a post-marketing study

Abstract

Oral administration of dydrogesterone during second half of menstrual cycle has been shown to reduce menstrual irregularities. This prospective, observational study aimed to determine continued effectiveness of dydrogesterone (prescribed between 1 and 6 cycles or longer) in menstrual cycle regularization in Indian women aged ≥18 years with irregular menstrual cycle for at least 3 months. Those achieving regular cycles (21 to 35 days, inclusive) during treatment were followed up for 6 months after cessation of dydrogesterone treatment. Of the 910 women completing dydrogesterone treatment, 880 (96.7%) achieved cycle regularization (p<0.0001 for 90% success rate) at end of treatment (EOT). Of the 788 subjects available for follow up at 6 months, 747 (94.8%) reported cycle regularity (p<0.0001 for 90% success rate). At EOT, the mean cycle duration reduced by 16.14 (±24.04) days and mean amount of menstrual bleeding decreased by 0.45 (±1.20) pads/day. While five subjects reported worst pain at baseline, none experienced it at EOT. One serious adverse event (appendicitis) and three non-serious adverse events were reported. Dydrogesterone regularizes and improves the duration of the menstrual cycle, reduces the amount of bleeding, relieves menstrual pain and prevents relapse of irregular cycles at six months after discontinuation of treatment.

Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding – ovulation dysfunction patients

“…In the subgroup analysis, the recovery ratewas more than 87% whilst the median MC duration for patients with polymenorrhea or oligomenorrhea was 29.1 d at the end of therapy, within the normal cycle (21-35 d). These results are comparable to the results of previous studies where regularization of MCs restored by dydrogesterone was discovered in 86.8%-99.1% of patients and the mean MC duration after treatment was around 27.7-29.8 d[ 7 , 9 - 11 ].…”

“…With respect to insulin sensitivity, Dansuk et al[ 22 ] found that dydrogesterone combining with 17 β-estradiol enhanced insulin sensitivity in postmenopausal women with 3 mo of treatment[ 22 ]. In addition, the safety of dydrogesterone has been confirmed in previous literature[ 7 , 9 - 11 ]. The associated AEs were also recorded throughout the treatment in the present study.…”

“…In addition, its retrostructure endows dydrogesterone with a highly selective property binding to the progesterone receptor[ 6 ]. However, although increasing evidence showed the good efficacy of dydrogesterone in treating menstrual disorders[ 3 , 7 - 10 ], studies focusing its efficacy for AUB-O patients are limited, especially in China where synthetic progestins are commonly prescribed for hemostasis and menstrual cycles regulation. Thus, the present prospective, single center, observational study was designed to assess the effectiveness of dydrogesterone for menstrual cycle regularization in Chinese AUB-O patients.…”

A prospective, open-label, single-arm study to evaluate the efficacy of dydrogesterone in the treatment of endometrial polyps

“…However, when compared with other progestin agents, dydrogesterone has not been associated with any unwanted metabolic side effects due to the absence of estrogenic, androgenic and glucocorticoid activity [6]. The various uses of dydrogesterone in published studies have supported its safety profile [22]. In our study, the participants reported no side effect, emphasizing the safety of dydrogesterone in clinical practice.…”

A Comparison between the Effectiveness of Norethisterone and Dydrogesterone for treatment of Irregular Menstrual Cycle

“…It has good efficacy in treating irregular menstrual cycles. Dydrogesterone is a C21 derivative and it has less androgenic side effects 9,10 . The lifetime prevalence of AUB is 5-15% and almost 1/3 rd of the gynecological outdoor consultations are done for the complaint of AUB in Pakistan 11 .…”